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Diabetes MellitusPhase 3PROTIDNCT04600167

Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus

A Phase 3 study testing Isoniazid and Rifapentine (INH-RPT) in people with Diabetes Mellitus and Tuberculosis, run by Dr. Nyanda Elias Ntinginya at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetes mellitus (DM) increases susceptibility to Tuberculosis (TB) and worsens TB patient outcomes. The number of patients with combined TB and DM now outnumbers that of combined TB and HIV and it has been estimated that 15-30% of TB disease may be attributable to diabetes globally. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Tuberculosis
What is being tested?
Isoniazid and Rifapentine (INH-RPT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,000 participants
Where
4 sitesin 2 countries
Study dates
17 Jun 2022to Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication ('known DM'); OR in the absence of anti-diabetic medication an HbA1c of =6.5% (48 mmol/mol) or a fasting venous plasma glucose of =7.0 mmol (126 mg/dl). For those with no previously known DM a repeat test above the diagnostic cut-point is required to confirm the diagnosis ('new DM')
  • Adult (18 years or older)
  • Diagnosed with LTBI, defined as a positive IGRA test or TST reactivity =10 mm
  • Voluntarily signed Informed Consent Form
  • If sexually active, willing to use an effective contraceptive method for the duration of preventive therapy.

Who cannot join

  • Weight <45 kg
  • Previous TB disease, defined as either bacteriologically confirmed or clinically diagnosed and treated
  • Treatment with a rifamycin medication or isoniazid in the previous 2 years.
  • Diagnosis of probable or definite TB during screening
  • Confirmed HIV-infection or receiving antiretroviral treatment
  • Liver dysfunction, defined as serum aspartate aminotransferase (AST) level 5 times the upper limit of normal
Show all 9Show fewer
  • Pregnant or planning to become pregnant in the next 3 months, or lactating
  • Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
  • Other conditions inapplicable for participation in this study, such as likely to fail to adhere to study commitment or to complete the whole study, at the discretion of the site investigator

Trial locations and contacts

4 sites in 2 countries.

Issa Sabi, MD, MMed, PhD contact

+255 25 250 3364

isabi@nimr-mmrc.org

Nyanda E Ntinginya, MD., MSc., PhD. contact

+255 25 250 3364

nelias@nimr-mmrc.org

4 sites in 2 countries

Tanzania2 sites, 2 recruiting

  • Mbeya zonal referral hospital

    Mbeya

    Nyanda E Ntinginya, MD, MSc, PhD, nelias@nimr-mmrc.org

    Issa Sabi, MD, MMed, PhD, isabi@nimr-mmrc.org

    Recruiting

  • Kilimanjaro Christian Medical Center

    Moshi

    Nyasatu Chamba, MD, MMed, nyasatuchamba@yahoo.com

    Kajiru Kilonzo, MD, MMed, k.kilonzo@kcri.ac.tz

    Recruiting

Other trials in Tanzania

Uganda2 sites, 2 recruiting

  • Makerere University

    Kampala

    Irene Andia- Biraro, MD, MMed, PhD, andiaodanga@yahoo.com

    Recruiting

  • Martyrs Hospital Lubaga

    Kampala

    Davis Kibirige, MD, MMed, PhD, kibirigedavis@gmail.com

    Recruiting

Other trials in Uganda

About this study

Official title: A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People With Diabetes

Diabetes mellitus (DM) increases susceptibility to Tuberculosis (TB) and worsens TB patient outcomes. The number of patients with combined TB and DM now outnumbers that of combined TB and HIV and it has been estimated that 15-30% of TB disease may be attributable to diabetes globally. This may be expected to rise substantially as DM prevalence increases. Treatment of Latent TB Infection (LTBI) in this population will likely have a significant clinical benefit. Similar to HIV-infected individuals, those with DM might benefit from therapy to prevent the development of TB disease. Current international guidelines do not recommend LTBI management in people with DM, but this is because no studies have examined the risk-benefit ratio of such an intervention. To date, no RCTs have been conducted to investigate the efficacy and safety of preventive treatment of LTBI in DM patients. Based on evidence on effectiveness, safety, and treatment completion rates, 3HP has been selected as the regimen of choice for this study of African people living with DM. People living with DM will be randomized to 3HP or placebo to determine the efficacy of 3HP in the prevention of TB disease in this population. PROTID's preventive treatment of LTBI among people with DM will generate the first solid evidence to support or refute the use of preventive treatment against TB in people with DM.

Being tested
Isoniazid and Rifapentine (INH-RPT), Placebo
Keywords
Tuberculosis, Drugs, Social science, Health systems, Epidemiology, Diabetes
Medical subject headings
Diabetes Mellitus, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isoniazid and Rifapentine (INH-RPT)Drug

    Also called 3HP

    Oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.

  • PlaceboDrug

    Participants in the control group will receive placebo once weekly for 12 weeks

Study groups in NCT04600167
Study groupRoleWhat they receive
Isoniazid and Rifapentine (INH-RPT)ExperimentalParticipants in intervention arm will receive an oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.
Receives: Drug: Isoniazid and Rifapentine (INH-RPT)
ControlPlacebo comparatorParticipants in the control arm will receive placebo once weekly for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First diagnosis of TB

    The primary outcome will compare the rate of occurrence of TB disease (defined as definite or probable TB) in treatment and control groups. Definite TB disease will be confirmed by a culture or Xpert positive result for M. tuberculosis. Probable TB will be diagnosed according to an algorithm that takes into account symptoms, chest x-ray reading, sputum smear, histology and verbal autopsy results.

    Measured: Through study completion, median of 33 months follow-up

Secondary outcomes (5)

  1. Occurrence of possible, probable or definite TB disease

    Measured: At least 24 months post randomisation

  2. Occurrence of an adverse event

    Measured: From randomisation to 60 days after end of study treatment

  3. Treatment completion

    Measured: Defined as > 11 of 12 doses of treatment over no more than 16 weeks.

  4. All-cause mortality

    Measured: At least 24 months post randomisation

  5. Occurrence of possible, probable, or definite TB, or death

    Occurrence of possible, probable, or definite TB, or death, noting that a proportion of deaths are likely to be due to TB but not possible to confirm through verbal autopsy and clinical notes review.

    Measured: At least 24 months post randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start17 Jun 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04600167
Sponsor's protocol ID
NIMR-MB-002
Acronym
PROTID
Status last verified
Mar 2023
First submitted
15 Sep 2020
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ntinginya NE, Te Brake L, Sabi I, Chamba N, Kilonzo K, Laizer S, Andia-Biraro I, Kibirige D, Kyazze AP, Ninsiima S, Critchley JA, Romeo R, van de Maat J, Olomi W, Mrema L, Magombola D, Mwayula IH, Sharples K, Hill PC, van Crevel R; PROTID Consortium. Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial. Trials. 2022 Jun 10;23(1):480. doi: 10.1186/s13063-022-06296-8.

    PubMed 35689272

  • Olomi W, Andia Biraro I, Kilonzo K, Te Brake L, Kibirige D, Chamba N, Elias Ntinginya N, Sabi I, Critchley J, Sharples K, Hill PC, Van Crevel R. Tuberculosis Preventive Therapy for People With Diabetes Mellitus. Clin Infect Dis. 2022 Apr 28;74(8):1506-1507. doi: 10.1093/cid/ciab755. No abstract available.

    PubMed 34505132

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Isoniazid and Rifapentine (INH-RPT) in people with Diabetes Mellitus and Tuberculosis, run by Dr. Nyanda Elias Ntinginya at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Tanzania, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Issa Sabi, MD, MMed, PhD (+255 25 250 3364, isabi@nimr-mmrc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First diagnosis of TB (time frame: Through study completion, median of 33 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600167, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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